Description
Product Overview
The AJ-GZA500 is a fully automated 3-in-1 filling and stoppering machine designed for RTU (Ready-To-Use) nested pre-filled syringes (PFS), cartridges, and vials. Featuring an integrated PLC + servo motor + pneumatic control architecture, this machine delivers precise filling via ceramic plunger pumps and reliable vacuum stoppering in a single compact system.
Engineered for GMP-compliant pharmaceutical production environments, the AJ-GZA500 combines high-speed output of 3,000–3,500 units per hour with filling accuracy of ±1.5% or better, making it ideal for GLP-1, insulin, and other injectable drug manufacturing lines.
Technical Specifications
| Parameter | Specification |
|---|---|
| Model Number | AJ-GZA500 |
| Applicable Materials | Liquid or Gel |
| Applicable Specifications | PFS 1ml long / 1–3ml / 5ml / 10ml; Cartridges 3ml (changeover parts required) |
| Filling Range | 0.1 – 10ml (plunger pump change required) |
| Filling Pump | Ceramic Plunger Pump (acid/alkali resistant, high-temperature resistant) |
| Injection Nozzles | 5 |
| Stoppering Nozzles | 5 |
| Filling Accuracy | ≤ ±1.5% |
| Production Capacity | 3,000 – 3,500 pcs/hour |
| Total Power | 15 KW |
| Power Supply | 380V 50Hz |
| Compressed Air | 0.6 – 0.7 MPa |
| Control System | Siemens PLC (S7-1200 + ET 200SP) with HMI (MTP-1500) |
| Servo System | Siemens V90 Servo Motor + Drive |
| Laminar Flow Hood | Class A (Included as Standard) |
| Dimensions (with Hood) | L2750 × W1200 × H2450 mm |
| Machine Weight | 1,500 KG |
Key Features
- GMP-Compliant Construction: SUS304 stainless steel surfaces; SUS316L product-contact parts with medical-grade silicone rubber.
- High-Precision Ceramic Filling: Ceramic plunger pump with acid/alkali corrosion resistance and filling accuracy ≤ ±1.5%.
- Anti-Splash Technology: Rising liquid level injection needle filling prevents drug solution splashing.
- International Brand Components: Siemens PLC/HMI/servo, Schneider electrical, SMC pneumatics, Panasonic/Omron sensors.
- Multi-Recipe Support: Multiple filling doses and formula parameter storage for quick product changeover.
- Real-Time Monitoring: HMI real-time station status display with automatic alarm and fault diagnosis.
- Built-In Audit Trail: Complete operation traceability, FDA 21 CFR Part 11 readiness.
- Integrated Laminar Flow Hood: Class A hood with built-in wind speed sensor for cleanroom-grade filling zone.
Product Details
Filling Mechanism — Ceramic plunger pump and injection nozzle assembly with capsule filter
Stoppering Station — SUS316L rubber stopper vibrating plate with detachable top plate
Ceramic Plunger Pump Assembly — Precision filling components
Compatible RTU Nested Pre-Filled Syringe Packaging Material
Filling Process Flow
- Nest Loading: RTU nested PFS/cartridges/vials are loaded onto the conveyor via the nest picking mechanism.
- Positioning: Servo motors precisely position the nest under the filling station.
- Filling: 5 ceramic plunger pump nozzles simultaneously fill containers using rising liquid level technology.
- Vacuum Stoppering: Vacuum negative pressure system inserts rubber stoppers into all 5 containers simultaneously.
- Quality Check: Real-time monitoring verifies fill volume and stopper placement.
- Output: Completed nest is transferred to the output conveyor for downstream processing.
Key Components
| # | Component | Model | Brand |
|---|---|---|---|
| 1 | HMI Touch Screen | MTP-1500 | Siemens |
| 2 | PLC Controller 1 | ET 200SP | Siemens |
| 3 | PLC Controller 2 | S7-1200 | Siemens |
| 4 | Servo Motor | V90 | Siemens |
| 5 | Servo Drive | V90 | Siemens |
| 6 | Switching Power Supply | PSU2200 | Siemens |
| 7 | Network Switch | XB005 | Siemens |
| 8 | Circuit Breaker | EA9AN3C40 | Schneider |
| 9 | Contactor | LC1N | Schneider |
| 10 | Intermediate Relay | RXZE1M2C | Schneider |
| 11 | Warning Light | XVGB3SW | Schneider |
| 12 | Push Button | ZB2-BE | Schneider |
| 13 | Conveyor Motor | 100YT200GV22 | JSCC |
| 14 | Solenoid Valve (+) | 4V210-08 | AirTAC |
| 15 | Solenoid Valve (-) | 4V210-08 | AirTAC |
| 16 | Pressure Regulator | GFR200-08 | AirTAC |
| 17 | Linear Guide | MGN12 | Hiwin |
| 18 | Ball Screw | SFU1204 | TBI |
Technical Drawings
3D Layout Drawing — Top View
Dimension Drawing — Front Elevation (H1850mm) and Plan View (L2750 × W1200mm)
Validation & Documentation
Delivered with complete validation documentation for pharmaceutical regulatory compliance:
- FAT (Factory Acceptance Test)
- SAT (Site Acceptance Test)
- DQ (Design Qualification)
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- Built-in Audit Trail for FDA 21 CFR Part 11 compliance readiness
Applications
Ideal for pharmaceutical and biotechnology manufacturers producing:
- GLP-1 receptor agonist pre-filled syringes and cartridges (semaglutide, liraglutide, tirzepatide)
- Insulin pen cartridge filling
- Multi-dose vial filling for injectable biologics
- Vaccine pre-filled syringe filling
- Any liquid or gel pharmaceutical requiring precision filling from 0.1–10ml
Optional Add-On Equipment
| Equipment | Model | Description | Status |
|---|---|---|---|
| Automatic De-lidding Machine | AJ-SMJ | Automated nest lid removal | Optional |
| Additional Mould Set | LEYRAY | For specification changeover | Optional |
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